Implantable tissue scaffold

ABSTRACT

A biodegradable scaffold for wound closure including a central rod and two spaced-apart plates. The central rod may have an engagement block on top for stabilizing an implanting tool. The two spaced-apart plates include an upper plate connected to the central rod and a lower plate connected to the central rod. Each of the upper and lower plates may include perforations which may be useful for detachably connecting an implanting tool and which encourage ingrowth of the tissue. The biodegradable scaffold allows tension free anatomic alignment of tissue within the plates and facilitates wound healing. The upper and lower plate may have a helical portion, in which each plate may extend around the central rod. The helical portion serves to draw or pull tissue around the wound defect into the scaffold in the course of deploying the scaffold.

RELATED APPLICATION

This Application claims priority from U.S. Provisional PatentApplication 62/778,634, entitled Implantable Tissue Scaffold, filed Dec.12, 2018.

FEDERAL GRANTS

This invention was made with government support under SBIR Grant Number1R43HD086896-01A1 NICHD awarded by the Small Business Administration.The government may have certain rights to the invention.

BACKGROUND Technical Field

The present invention generally relates to a wound closure device andmore specifically to a wound closure device to repair a defect leftduring laparoscopic (minimally invasive) surgery.

Laparoscopic surgery was introduced as an alternative to open surgicalmethods. Also referred to as minimally invasive surgery, the techniqueallows for small incision access to the intra-abdominal cavity, or otherinternal body cavities. The approach utilizes specialized equipment suchas robotics for the purposes of inflating the abdominal cavity with gas,deploying and exchanging instruments during the operation, and real timeimaging with a videoscopic camera.

A laparoscopic trocar is a surgical device used for laparoscopicprocedures to pierce and access the wall of an anatomical cavity,thereby forming a passageway providing communication with the inside ofthe cavity. Other medical instruments such as videoscopes and operatinginstruments can thereafter be inserted through the passageway to performvarious medical procedures within the anatomical cavity. The generalbackground is also discussed in U.S. Pat. No. 9,615,817 to Bippart etal. which is hereby incorporated by reference for all purposes herein.

When the procedures are over, the laparoscopic trocar is removed,leaving a residual defect in the fascia-peritoneal layer. Laparoscopictrocars are typically 5-15 mm in diameter. The risk of herniationincreases as the trocar size increases, and it is generally recommendedthat any port size larger than 5 mm should be closed because of the riskof hernias. The residual fascia peritoneal layer defect is located deepin the abdominal wall, making it difficult to view and for the surgeonto repair.

Trocar site herniation is a recognized complication of laparoscopicsurgery. Omental, and sometimes intestinal, herniation withincarceration and obstruction has been documented in recent surgicalliterature, occurring at any trocar insertion site larger than 5 mm thatwas not properly sutured at operation. The necessity to perform fascialclosure of any trocar insertion site larger than 5 mm has now beenestablished and is routinely practiced worldwide.

However, the closure of such a trocar site fascial defect using theconventional suturing technique is often technically difficult,frustrating, unreliably successful, and even sometimes dangerous due tothe limited size of skin incision, the thickness of the subcutaneousfatty layer, and necessity of blind manipulation. Moreover, the suturingthat involves placement of deep blind sutures after the abdomen has beendecompressed is a dangerous manipulation that surgeons prefer to avoid.

A number of techniques and instruments have been proposed to facilitatea safe and secure closure of the fascial defect through the tiny skinopening. Many of these repairs include passing in any way a suture fromone side of the trocar wound to the other, and its ligation. For thispurpose either a curved needle or a variety of straight needles throughwhich sutures are passed have been used. Problems arise as both sides ofthe defect may not be sutured. Also, in overweight and obese patientswith thick abdominal walls, reliable fascia closure is very difficult toachieve. This results in a delayed hernia formation such as anincarcerated or symptomatic hernia. The literature shows as much as a 6%overall hernia complication rate, resulting in reoperation,rehospitalization, and extended disability. In the worst case thisresults in the need for an emergent repair, resulting inrehospitalization.

Suturing techniques require positioning of the camera and grasping,visualization of the needles during their entrance into the peritonealcavity, feeding of the graspers or suture passers with the suture loop,all of which are repeated once or twice for every trocar defect closed.Any of these suturing techniques are not only time and effort consuming,even in the best of hands. As more defects at various sites in theabdominal wall are to be closed after advanced laparoscopic operations,the suturing techniques have become more complicated and tedious.

Techniques using instruments such as suture passers work by adding acatch onto the end of a needle assembly. These guide positioning of thesuture fixed point beyond the edges of the trocar defect and assureprimary closure when direct visualization is limited from the outside.Intracorporeal laparoscopic closure techniques employ suture passerswith a modified clasp or spacers at the end of the needle assembly.These guide positioning of the suture at a fixed point beyond the edgeof the trocar defect and assure primary closure when directvisualization is limited from the outside and conventional suturing isnot possible.

Moreover, a series of manipulations is needed to complete a singlesuturing. The conventional suturing technique involves much traumaticmanipulation including pushing, pulling and retraction of the wound, andinsertion and extraction of needles. Most of the time the needle ispassed twice, and sometimes more. As manipulation in the woundincreases, the inflammation and risk of ensuing infection riseconsiderably. The edema and the collection of seroma and hematoma at thewound further cause dehiscence and hernia formation on a long-termbasis.

Excessive traumatic manipulation and suturing with heavy sutures opposethe “minimally invasive” basis of laparoscopic surgery. The patients aresubject to pain and complications at their trocar sites in thepostoperative period.

Tedious intra-corporeal suturing techniques can be used to dose trocarport defects under direct vision from within the abdominal cavity, butthis is rarely done. Instead, most trocar ports are dosed from theoutside, with the abdominal wall in a flattened configuration.

As a result, the residual defect within the fascial layer is poorlyvisualized by the surgeon. No matter which suturing technique or needleis used, it is not possible to eliminate the trocar site herniascompletely. As described in Malazgirt (US Patent Application, pub#20060015142 published Jan. 19, 2006), the current incidence isreportedly between 0.77-3%.

As complex laparoscopic surgery has become more common, the incidence ofthis complication has also increased. The reported rates of hernia showthat there is not yet any superior method in the safe closure of thetrocar fascial defect.

U.S. Pat. No. 6,120,539 issued Sep. 19, 2000 proposed a prostheticrepair fabric constructed from a combination of non-absorbabletissue-infiltratable fabric which faces the anterior surface of thefascia and an adhesion-resistant barrier which faces outward from thefascia. This prosthetic requires the use of sutures to hold it in place.

U.S. Pat. No. 5,366,460, issued Nov. 22, 1994 proposed the use of anon-biodegradable fabric-coated loop inserted through the defect intothe fascia wall, pressing against the posterior fascia wall from theintra-abdominal pressure.

U.S. Pat. No. 6,241,768, issued Jun. 5, 2001 proposed a prostheticdevice made of a biocompatible non-biodegradable mesh, which sits acrossthe fascia defect using the abdominal pressure to hold it in place.

US Published Patent Application 2003/0181988 proposed a plug made ofbiocompatible non-biodegradable material which covers the anterior sideof the fascia, the defect, as well as the posterior side of the fascia.

US Published Patent Application 2006/0015142 proposed a plug/meshnon-biodegradable combination for repair of large trocar wounds. It isstated that it requires at least a “clean flat area around with a radiusof 2.5 cm”, and requires staples to hold it in place.

Ford and Torres (Pat Pub #20060282105) proposed a patch with a tether orstrap, all made of non-biodegradable biocompatible material placedagainst the anterior wall of the fascia defect.

All of the above references are hereby incorporated by reference as iffully set out herein.

SUMMARY

One embodiment of the invention is an implantable tissue scaffold forwound closure which includes a central rod, an upper plate angularlypositioned on the central rod; and a lower plate that is also angularlypositioned on central rod. The spacing on the central rod of the upperand lower plate is determined by the thickness of the defect caused bythe laproscopic tocar, and may vary. This allows the tissue scaffold tobe positioned such that one plate is on a tissue surface on one side ofthe tunnel like defect, and the other plate is on the other side of thetunnel like tocar defect. One unique feature of the implantable tissuescaffold is that it is a single, unitary piece. This allows the tissuescaffold to be adaptable to 3-D printing, and simpler to manufacture asit has no moving parts. Another unique feature is that it is made of abiodegradable material, which will biodegrade once placed within 3-5months.

The tissue scaffold may have a number of configurations. For example,the upper and lower plates may be in part essentially perpendicular tothe central rod. The upper and lower plates may be divided intofractional sections, such as quadrants, which are circumferentiallypositioned about the central rod. One or more of the upper and lowerplate may camber helically. Such a shape aids the implantable tissuescaffold in seating on either side of the trocar defect. The surface ofthe plates may include features to both promote tissue growth throughthe tissue scaffold and to aid in gripping the device by an implantingor placement tool. For example, the upper and lower plates may includeperforations, such as an inner and outer row of perforations through theupper and lower plates. These perforations promote through growth andallow a tool, such as a gripping tool, to position/implant theimplantable tissue scaffold.

Such perforations on the upper and lower plates may be in multiple rows.These perforations reduce the material required to manufacture thedevice, provides a feature to grip onto the device by a tool, andpromotes tissue ingrowth.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a first side view of an embodiment of the invention.

FIG. 2 shows a second side view of an embodiment of the invention.

FIG. 3 shows a third side view of an embodiment of the invention, FIGS.1-3 showing various views about the circumference of an embodiment ofthe invention.

FIG. 4 shows a top view an embodiment of the invention.

FIG. 5 shows a side perspective view of an embodiment of the inventionshowing the upper sides of the upper and lower plates.

FIG. 6 shows a side perspective view of an embodiment of the inventionshowing the lower sides of the upper and lower plates.

FIG. 7 shows a bottom view of an embodiment of the invention.

FIG. 8 shows a diagram of one or more embodiments of the device insertedinto a wound.

DETAILED DESCRIPTION

Specific embodiments and examples are illustrated in the figures anddescribed in the detailed description. However, it is envisioned thatthe disclosed tissue scaffold may be put into practice using any of anumber of elements, and could be made using a variety of methods,whether presently known or not. The present disclosure should in no waybe limited to the exemplary implementations and techniques illustratedin the drawings and described below. In addition, elements, features anddesigns illustrated in the drawings are not necessarily drawn to scale.

In one or more embodiments, as shown in FIG. 1 , the device includes acentral rod 102, an engagement block attached to the one end of thecentral rod 104, an upper plate 106, and a lower plate 108 essentiallyperpendicular to the central rod 102. The plates are at least in partessentially parallel to each other with enough space between to allowthe tissue to seat without direct compression. This spacing is designedfor the average tissue thickness at common sites of trocar insertion. Ininitial tests it has been found that even when the implantable tissuescaffold is too small to seat at the outer and inner peripheral edges ofa trocar defect, the device still has clinical benefit. For example, inobese patients, the tissue thickness may be variable, and the trocarinsertion may leave a larger defect. In such instances it has been foundthat the implantable tissue scaffold may position within a passageway ofthe defect and results in tissue ingrowth prior to devicebiodegradation.

In one embodiment, the upper and lower plates are designed in ascrew-like manner, such that opposing ends of the upper plate 106 areattached to the engagement block 104 on the central rod 102, and thatthe upper end of the upper plate 106 aligns with the top side of theengagement block 104, and the lower end of the upper plate 106 alignswith the bottom side of the engagement block 104. In this embodiment,the base element of each plate is a three-quarter circle where the firstand second quadrants are essentially perpendicular to the engagementblock 104, and the third quadrant cambers helically. The corner of thefirst quadrant is rounded to avoid any sharp edges, while the edge ofthe third quadrant has a semi-circular attachment which attaches on oneside to the outside of the inner edge and on the inside to where theedge meets the central rod 102. The quadrant that is helical on theupper plate 106 is the opposite of the quadrant of the lower plate 108supporting defect edges of tissue alignment where the scaffold isencouraged to stay near the wound without injuring the tissue.

The term scaffold as used here is to define the surfaces of the upperplate and lower plate which contact and align the tissue, into which thetissue will grow as the plates disintegrate. In one embodiment, theupper and lower plates have perforations which aid in this process.

In other embodiments, the first and third quadrants of each of the upperplate 106 and lower plate 108 are perpendicular to the central rod 102,while the middle quadrant is helical in the same direction. Howeverinstead of a single 90-degree arc, the third quadrant provides acomplete loop as well, about 5 quadrants or 450 degrees, which providesmore of a grabbing effect on the tissue between the two plates, furtherencouraging the scaffold to stay aligned with the wound. The termquadrants are illustrative of a division of the plates into fractionalsections. The plates are circumferential about the central rod 102.These plates may be something less than 360 degrees about the centralrod, make a single 360 degree covering, or include 5 quadrants and beabout 450 degrees to magnify the grabbing effect of the device.

FIG. 2 shows a side view of the device showing the lower end 112 of thelower plate 108 and the lower end 114 of the upper plate 106. This viewshows the lower base perforations 110 which are present on the lowerplate. In one or more embodiments, there are one or more perforationspresent in each quadrant of the plate. The lower base perforations 110both encourage growth into the scaffold and reduce the weight of thedevice. In addition, the perforations could be a feature to allow a toolto grip onto the implantable tissue scaffold and position the device.Although upper plate 106 and lower plate 108 are shown havingessentially flat surfaces, it is contemplated that textured surfacescould be used to aid in the stable positioning of the device. In thisillustrated embodiment, the perforations are elliptical, however anyvariety of shapes are possible. These perforations shown pass throughthe entire plate and are uniform in diameter. It is also contemplatedthat the pore shapes could taper, be more circular or angular or haveother shapes or designs. The illustration shows the perforations in boththe lower and upper plates with one set of perforations disposed closerto the central rod.

FIG. 3 shows a side view of an embodiment looking at a different sideview of the device, such that the lower end 114 of the upper plate 106and the lower end 112 of the lower plate 108 are on the opposite side ofthat shown in FIG. 2 .

FIG. 4 shows a top view of an embodiment of FIGS. 1-3 , showing theengagement block 104 connected to the upper plate 106, the lower end ofthe upper plate 114 and the upper plate perforations 110. The upperplate perforations 110 serve both to encourage growth as well as toprovide a place for the instrument placing the device into the wound tohold and stabilize it. As shown, upper plate perforations 110 are largerthan the perforations of lower plate 108, and instead of an ellipticalshape has a flat surface closest to the central rod 102, two essentiallyperpendicular side walls and a curved outer wall at the radial greaterdistance from central rod 102. These larger perforations with flatsurfaces are more suited to grasping by a positioning tool duringimplantation of the implantable tissue scaffold.

FIG. 5 shows a side perspective view of an embodiment, looking down atthe top of the device at an approximate 45-degree angle.

FIG. 6 shows an upward view of an embodiment, looking up at the bottomof the device a tan approximate 45-degree angle.

FIG. 7 shows a bottom view of an embodiment.

FIG. 8 shows an embodiment of the device in place, inserted into thewound of the tissue 116. The device acts to hold the tissue in placearound the wound 118 with minimal harm to the tissue. The central rod102 may be between 20 and 95% of the width of the wound 118, with arange of 25-50% of the width of wound 118 expected to be more preferred.The width of the tissue scaffold is scaled to the wound width, with theplates extending over the edges of the wound such that at least 10% ofthe width of the upper and lower plate is seated against the upper andlower edge of wound 118, with an 11% to 25% radial overlap considered toprovide greater stability and a 50% overlap providing maximal stabilityand chance for tissue ingrowth while still allowing the central rod tofit through the wound opening during insertion of the insertable tissuescaffold. The general width of the device will be matched to the size ofthe trocar used in the minimally invasive procedure. A device having awidth of between 5 and 15 mm would be used on most defects. Scaffolds ofvariable sizes may be used to repair tissue defects of variable sizes.Larger diameter tissue scaffolds may be required to repair eccentricshaped abdominal defects. It is envisioned that in clinical use, thedefect could be measured and the scaffold manufactured (e.g. by 3Dprinting) on demand proximate to an operating room to allow the tissuescaffold to be tailored to the defect being repaired. Alternatively, thetissue scaffold can be selected from a variety of manufactured sizes toaccommodate defects of differing depth and widths. Given that trocarsare in standard sizes, it is believed that standard sized tissuescaffolds could be utilized for the routine trocar defect sizes.

As illustrated in FIG. 8 , in order to optimize tissue alignment andhealing and to reduce the risk of hernia complications, the scaffold isdesigned to extend beyond the edges of the defect. This anchors thedevice and prevents extrusion of prolapse of the scaffold during thehealing biodegradation period.

In one or more embodiments, the device is used as follows. An insertiondevice is detachably coupled from above the upper plate 114 by couplingwith the upper plate perforations 110, using the engagement block 104 toprovide stability. After the trocar has been removed from the abdominalwall entry site, the joined insertion device and attached scaffold areplaced in the trocar port site and positioned such that the lower plate108 engages the peritoneal layer of the intra-abdominal cavity and/orthe fascia muscle layer within the length of the tissue tunnel. Thehelical shape contains a camber feature that services to draw or pulltissue around the wound defect into the scaffold during the course ofdeploying the scaffold. At that point in time, the insertion tool can bedetached from the scaffold and removed from the operative field. Theimplantable scaffold has engaged tissue between the upper plate 106 andlower plate 108, securing tissue in anatomical alignment while thetrocar port has time to heal. The upper plate perforations 110 and lowerbase perforations 110 are there to encourage the tissue ingrowth intothe scaffold and facilitate healing of the trocar port defect.

As shown in the illustrated embodiments, the upper plate 106 and lowerplate 108 have two quadrants that are essentially parallel to each otherand are displaced from each other by a single plate thickness. A thirdquadrant is cambered to allow the upper and lower plates to have anessentially uniform thickness while one quadrant is one plate thickensfurther up or down the central rod 102. This is best shown visualized inFIG. 5 . This cambered helical structure and curved edges of the platesprovide a tactile feel fo the scaffold during implantation, aids in theproper seating of the device and provides useful haptic feedback andassurance that the tissue scaffold is securely engaged with the tissue.

General Composition of the Wound Closure Device

Materials specified for the wound closure device are specific for itsintended application and use. The scope of materials that will satisfythe requirements of this application is unusually narrow. This is adirect consequence of the specificity and functional demandscharacteristic of the intended surgical application.

The intention for the wound closure device is to close and secure thetrocar port defect in the fascia. This requires a known and finitehealing interval of some three to five months. Its purpose fulfilled atthe end of this period, making continued presence of the closure devicea potential liability. Maurus and Kaeding (Maurus, P. B. and Kaeding, C.C., “Bioabsorbable Implant Material Review”, Oper. Tech. Sports Med 12,158-160, 2004) describe the advantages of a device that isbiodegradable. This means that the materials will degrade ordisintegrate, being absorbed in the surrounding local tissue environmentafter a definite, predictable, and desired period of time. One advantageof such materials over non-degradable or essentially stable materials isthat after the interval for which they are applied (i.e. healing time)has elapsed, they are fully biodegraded and do not act as a residualforeign body. This is most significant as it minimizes risks associatedwith foreign body reaction, chronic inflammation and/or suturegranuloma. Furthermore, the presence of the scaffold structure supportstension free anatomic alignment of the tissue defect and facilitateswound healing.

A disadvantage of these types of materials is that their biodegradablecharacteristic makes them susceptible to degradation under normalambient conditions. There is usually sufficient moisture or humidity inthe atmosphere to initiate their degradation even upon relatively briefexposure. This means that precautions must be taken throughout theirprocessing and fabrication into useful forms, and in their storage andhandling, to avoid moisture absorption. This is not a serious limitationas many materials require handling in controlled atmosphere chambers andsealed packaging; but it is essential that such precautions areobserved. Middleton and Tipton (Middleton, J. and Tipton A. “SyntheticBiodegradable Polymers As Medical Devices” Medical Plastics andBiomaterials Magazine, March 1998) found that this characteristic alsodictates that their sterilization before surgical use cannot be doneusing autoclaves, but alternative approaches must be employed (e.g.exposure to atmospheres of ethylene oxide or gamma radiation with cobalt60).

While biodegradability is an essential material characteristic for thewound closure device, the intended application is such that a furtherrequirement is that the material is formulated and manufactured withsufficient compositional and process control to provide a preciselypredictable and reliable degree of biodegradability. The period ofbiodegradability corresponds to the healing interval for the trocardefect in the fascia layer, which is typically three to five months.

In these materials, simple chemical hydrolysis of the hydrolyticallyunstable backbone of the polymer is the prevailing mechanism for itsdegradation. As discussed in Middleton and Tipton (Middleton, J. andTipton A referenced previously), this type of degradation when the rateat which water penetrates the material exceeds that at which the polymeris converted into water-soluble materials is known as bulk erosion.

Biodegradable polymers may be either natural or synthetic. In general,synthetic polymers offer more advantages than natural materials in thattheir compositions can be more readily finely-tuned to provide a widerrange of properties and better lot-to-lot uniformity and, accordingly,offer more general reliability and predictability and are the preferredsource.

Synthetic absorbable materials have been fabricated primarily from threepolymers: polyglycolic acid (PGA), polylactic acid (PLA) andpolydioxanone (PDS). These are alpha polyesters or poly (alpha-hydroxy)acids. The dominant ones are PLA and PGA and have been studied forseveral decades. Gilding and Reed (Gilding, D. K and Reed A. M.,“Biodegradable Polymers for Use in Surgery” Polymer 20, 1459-1464)discussed how each of these materials has distinctive, uniqueproperties. One of the key advantages of these polymers is that theyfacilitate the growth of blood vessels and cells in the polymer matrixas it degrades, so that the polymer is slowly replaced by living tissueas the polymer degrades.

In recent years, researchers have found it desirable for obtainingspecific desirable properties to prepare blends of these two dominanttypes, resulting in a highly useful form, or co-polymer, designated asPLGA or poly (lactic-co-glycolic acid). Asete and Sabilov (Asete, C. E.and Sabilov C. M., “Synthesis and Characterization of PLGANanoparticles”, Journal of Biomaterials Science—Polymer Edition 17 (3)247-289 (2006)) discuss how this form is currently used in a host ofFDA-approved therapeutic devices owing to its biodegradability andbiocompatibility.

In one or more embodiments, the biodegradable wound closure device maybe made of biodegradable material of different stability (i.e.half-life). While it is important for the material that is in directcontact with the fascia needs to stay in place for a few months, whilethe rest of the implantable structure can degrade significantly in amatter of weeks without affecting the performance of the payload. In oneor more embodiments.

We claim:
 1. An implantable tissue scaffold for closing a wound defectcomprising: one central rod having a central longitudinal axis; an upperplate including an upper section, a lower section disposed below theupper section, and a middle section attached to the central rod andconnecting the upper and lower sections, the upper, middle and lowersections collectively at least partially circumscribing the central rod,the middle section being a helical section that at least partiallycircumscribes the central rod, the upper plate having a first end and anopposite second end that is each connected to the central rod, each ofthe upper section and lower section being perpendicular to thelongitudinal axis of the central rod, a lower end of the lower sectionbeing fixed to the central rod; and a lower plate spaced-apart from theupper plate, the lower plate including an upper section, a lower sectiondisposed below the upper section of the lower plate, and a middlesection attached to the central rod and connecting the upper and lowersections of the lower plate, the upper, middle and lower sections of thelower plate collectively at least partially circumscribing the centralrod, the middle section of the lower plate being a helical section thatat least partially circumscribes the central rod, the lower plate havinga first end and an opposite second end that is each connected to thecentral rod, each of the upper section and lower section of the lowerplate being perpendicular to the longitudinal axis of the central rod, alower end of the lower section being fixed to the central rod; thehelical section of the upper plate and/or the helical section of thelower plate including a camber feature that is configured to draw tissuearound the wound into the scaffold, the central rod, upper plate andlower plate comprising a single unitary piece made of a biodegradablematerial.
 2. The implantable tissue scaffold according to claim 1,wherein the helical section of one or both of the lower plate and upperplate circumscribes the central rod by less than 360 degrees.
 3. Theimplantable tissue scaffold according to claim 1, wherein the helicalsection of one or both of the lower plate and upper plate circumscribesthe central rod by greater than 360 degrees.
 4. The implantable tissuescaffold according to claim 1, wherein one or both of the upper plateand lower plate includes a geometry that promotes tissue ingrowth intothe respective upper plate and lower plate.
 5. The implantable tissuescaffold of claim 4, wherein the geometry that promotes tissue ingrowthincludes a plurality of perforations.
 6. The implantable tissue scaffoldaccording to claim 5, wherein the plurality of perforations includethrough holes in the one or both of the upper plate and lower plate. 7.The implantable tissue scaffold according to claim 5, wherein theplurality of perforations include a first set of perforations and asecond set of perorations, the first set of perforations being locatedradially nearer the central rod than the second set of perforations. 8.The implantable tissue scaffold according to claim 1, wherein one orboth of the upper and lower plates includes a textured surface.
 9. Theimplantable tissue scaffold according to claim 1, wherein thebiodegradable material is configured to completely biodegrade in threeto five months after being implanted into a laparoscopic port defect.10. The implantable tissue scaffold according to claim 1, wherein thelower and upper plates comprise a same shape.
 11. The implantable tissuescaffold according to claim 10, wherein the lower and upper plates arearranged about the central rod in a same way.
 12. The implantable tissuescaffold according to claim 1, wherein the upper section of the upperplate includes a first flat surface that lies in a first plane that isperpendicular to the central longitudinal axis of the central rod andthe upper section of the lower plate includes a second flat surface thatlies in a second plane that is perpendicular to the central longitudinalaxis of the central rod, the first flat surface and the second flatsurface being parallel to one another and facing one another.
 13. Theimplantable tissue scaffold according to claim 1, wherein the lowersection of the upper plate includes a first flat surface that lies in afirst plane that is perpendicular to the central longitudinal axis ofthe central rod and the lower section of the lower plate includes asecond flat surface that lies in a second plane that is perpendicular tothe central longitudinal axis of the central rod, the first flat surfaceand the second flat surface being parallel to one another and facing oneanother.
 14. An implantable tissue scaffold for closure of alaparoscopic tissue defect comprising: a tissue scaffold body scaled toa laparoscopic trocar port defect, the scaffold body including: onecentral rod having a central longitudinal axis; an upper plate includingan upper section, a lower section disposed below the upper section, anda middle section attached to the central rod and connecting the upperand lower sections, the upper, middle and lower sections collectively atleast partially circumscribing the central rod, the middle section beinga helical section that at least partially circumscribes the central rod,the upper plate having a first end and an opposite second end that iseach connected to the central rod, each of the upper section and lowersection being perpendicular to the longitudinal axis of the central rod,a lower end of the lower section being fixed to the central rod; and alower plate spaced-apart from the upper plate by a defect thicknessdimension, the lower plate including an upper section, a lower sectiondisposed below the upper section of the lower plate, and a middlesection attached to the central rod and connecting the upper and lowersections of the lower plate, the upper, middle and lower sections of thelower plate collectively at least partially circumscribing the centralrod, the middle section of the lower plate being a helical section thatat least partially circumscribes the central rod, the lower plate havinga first end and an opposite second end that is each connected to thecentral rod, each of the upper section and lower section of the lowerplate being perpendicular to the longitudinal axis of the central rod, alower end of the lower section being fixed to the central rod; thehelical section of the upper plate and/or the helical section of thelower plate including a camber feature that is configured to draw tissuearound the laparoscopic tissue defect into the scaffold, the centralrod, upper plate and lower plate comprising a single unitary piece madeof a biodegradable material.
 15. The implantable tissue scaffoldaccording to claim 14, wherein the helical section of one or both of thelower plate and upper plate circumscribes the central rod by less than360 degrees.
 16. The implantable tissue scaffold according to claim 14,wherein one or both of the upper plate and lower plate includes aplurality of perforations that promote tissue ingrowth into therespective upper plate and lower plate.
 17. The implantable tissuescaffold according to claim 16, wherein the plurality of perforationsinclude through holes in the one or both of the upper plate and lowerplate.
 18. The implantable tissue scaffold according to claim 14,wherein the lower and upper plates comprise a same shape and a same sizeand are arranged about the central rod in a same way.
 19. Theimplantable tissue scaffold according to claim 12, wherein the lowersection of the upper plate includes a third flat surface that lies in athird plane that is perpendicular to the central longitudinal axis ofthe central rod and the lower section of the lower plate includes afourth flat surface that lies in a fourth plane that is perpendicular tothe central longitudinal axis of the central rod, the third flat surfaceand the fourth flat surface being parallel to one another and facing oneanother.